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Terminated

25 gauge VersaVit 2.0 Vitrectomy Cutter, Product/Part Number 70935, packaged in a Tyvek/Mylar double pouch configuration.

FDA Recall Z-0122-2017 · Posted 2016-10-18

Recalling FirmSynergetics Inc
Recall StatusTerminated
Product CodeHQE
Date Initiated2016-08-11
Date Terminated2017-04-27
Product Quantity9 units

Reason for Recall

Vitrectomy cutters have been found not to be operating within the correct pressure pulse per specification.

Firm Action

A customer notification letter was sent out on 8/11/2016 to the hospital/surgical center level. Customers were asked to fill out and return a recall acknowledgment form and send back any affected devices.

Root Cause

Other

Distribution Pattern

Devices were distributed to KY, VA, TN, OH, IN, CA, NJ, NY, TX, SC, AL, MS, MI, and UT. Foreign distribution to the UK, France, Mexico, and India.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K121675VERSAVITSynergetics, Inc. · 2012-06-21

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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